The Effects of Timolol On Healing and Cosmesis of Mohs Scalp Wounds: An Open Label Trial

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeisinger Clinic

About this trial

The goal of this study clinical trial is to learn if topical timolol can accelerate healing and improve the cosmetic appearance of surgical wounds on the scalp following Mohs surgery. It will include Geisinger patients 18 year or older who undergo Mohs surgery of the scalp with planned wound healing by secondary intent. The main questions in aim to answer are:

1. Compare wound healing speed between patients treated with topical timolol and those receiving standard wound care only. 2. Compare cosmetic outcomes using topical timolol and standard wound care. 3. Evaluate the impact of topical timolol on the number of unplanned follow-up visits and calls related to delayed wound healing.

Participants will be asked use either topical timolol or use standard wound care to treat their Mohs surgery scalp wound. They will follow-up around 4, 8 and 12 weeks.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Known allergy or sensitivity to timolol or any components of the study medication.

Bronchial asthma or history of bronchial asthma

Severe chronic obstructive pulmonary disease (COPD)

Sinus bradycardia

Trial design

Design model

Parallel

Treatments tested in this trial

  • Topical Timolol

    Drug

    Topical timolol is the active drug that will be compared to placebo in the trial.

  • Normal Saline

    Drug

    Normal saline is the placebo that will be compared to topical timolol in the trial.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Timolol ArmActive comparator 1 intervention
Group B: Standard of Care ArmPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Healing At 12 Weeks

Percentage of patients achieving complete re-epithelialization at 12 weeks

Time frame
From treatment start to follow up 12 weeks later
2

Scar Cosmesis

Scar cosmesis calculated using visual analog scale (VAS)

Time frame
Calculated at 4, 8, and 12 week follow up after treatment start.

Secondary outcomes

1

Healing At 8 Weeks

Percentage of patients achieving complete re-epithelialization at 8 weeks

Time frame
From treatment start to follow up 8 weeks later
2

Healing At 4 Weeks

Percentage of patients achieving complete re-epithelialization at 4 weeks

Time frame
From treatment start to follow up 4 weeks later
3

Change In Wound Area at Follow Up

Percentage change in overall wound area at specified follow up windows.

Time frame
Calculated at 4, 8, and 12 week follow up after treatment start.
4

Calls for Non-healing Wounds

The number of calls made to our clinic for non-healing wounds or other wound related concerns.

Time frame
From treatment start to 12 weeks.

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: